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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Control — Class IIb MDR by Artsana S.p.A.

MD Atlas
Artsana S.p.A.

EUDAMED last updated this device on Mar 5, 2024

Control

805866409053000QF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Artsana S.p.A.
UDI-DI code: 08058664099511
Reference / catalog number: 00009734000100

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View device family (Basic UDI)

Manufacturer information

Organization name: Artsana S.p.A.
SRN: IT-MF-000010731
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Spain		Still on market

Device identification

Trade name: Control
UDI-DI code: 08058664099511
Basic UDI-DI: 805866409053000QF
Reference / catalog number: 00009734000100
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08058664099511

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

Certificate health across this manufacturer's portfolio.

CSQ001423Issued
Quality management systemNotified body: 0373Expiry: Nov 1, 2028